Home-Based Programs for Improving Sleep in Cancer Survivors

NCT00993928 | Terminated Phase 2 Results DMC

• 3 other identifiers: NCCTG-N07C4NCI-2011-01978CDR0000656564
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 193

Brief Summary

RATIONALE: Following a program that uses written materials and pre-recorded mp3 devices may help improve the sleep of cancer survivors. It is not yet known which home-based program is more effective in improving the sleep of cancer survivors. PURPOSE: This randomized phase II trial is comparing two home-based programs for improving sleep in cancer survivors.

Conditions

Cancer Survivor; Fatigue; Psychosocial Effects of Cancer and Its Treatment; Sleep Disorders

Keywords

psychosocial effects of cancer and its treatment; fatigue; sleep disorders; cancer survivor

Outcome Measures

Primary Outcomes (1)

• Change of the (3 Day) Sleep Latency Time and Time to Fall Back Asleep After Awakening During the Night From Baseline to the End of Study at Week 7

  The primary analysis will compare the change in time (in minutes) to fall asleep from baseline to week 7 as reported by question 3 in the sleep diary: "How long did it take you to get to sleep last night?" and time to fall back asleep after awakening during the night as reported by question 6A on sleep dairy: "When waking up after first falling asleep, how long did it take you to fall back to sleep?" \> \> Data were analyzed as a percent change from baseline to week 7. The percent change were compared between arms using a Wilcoxon rank-sum test.

  Baseline and 7 weeks

Secondary Outcomes (4)

• Efficacy of Home-based Interventions on the Number of Awakenings After Sleep, Sleep Quality, Sleep Difficulty, and Sleep Latency at Baseline and Weeks 4 and 7.

  Baseline and 7 weeks

• Comparing the Efficacy of Two Home-based Sleep Interventions as Therapy for Sleep-wake Disturbances as Measured by the Percent of People Who Show Improved Sleep Per the Pittsburgh Sleep Quality Index (PSQI)

  Baseline and 7 weeks

• Total Mood Disturbance as Measured by Profiles of Mood States B (POMS-B)

  At baseline and week 7

• Distress at Week 6

  From baseline to week 7

Study Arms (2)

Arm A: Home-based sleep intervention with Device #1

EXPERIMENTAL

Participants listen to a pre-recorded mp3 device #1 before retiring to sleep. Only patients in Arm A will have assigned bed and wake times based on their baseline diary.

Behavioral: Home-based sleep intervention

Arm B: Home-based sleep intervention with Device #2

ACTIVE COMPARATOR

Participants will listen to a pre-recorded mp3 device #2 before retiring to sleep. At the end of the study, participants assigned to pre-recorded mp3 device #2 will be offered pre-recorded mp3 device #1 for their own use.

Behavioral: Home-based sleep intervention

Interventions

Home-based sleep intervention BEHAVIORAL

Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.

Arm A: Home-based sleep intervention with Device #1; Arm B: Home-based sleep intervention with Device #2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Prior diagnosis of cancer * At least 2 months and ≤ 24 months since completed curative-intent treatment (chemotherapy, surgery, and/or radiotherapy) * Ongoing hormonal therapy (i.e., tamoxifen, aromatase inhibitors, casodex) * Concurrent trastuzumab and maintenance rituximab allowed * Sleep difficulty defined as self report of sleep latency of ≥ 30 minutes on 3 out of 7 nights in a week and wishing therapeutic intervention, and/or self report of waking up after first falling asleep and not being able to fall back asleep for ≥ 30 minutes on 3 out of 7 nights in a week * No history of diagnosis of primary insomnia (patient medical record, defined by having had behavioral, cognitive, or pharmacologic treatment) for \> 30 consecutive days in the year before cancer diagnosis * No active cancer (i.e., not considered no evidence of disease) * No concurrent CNS malignancy * No history of diagnosed sleep disorder (i.e., obstructive sleep apnea, restless legs, or periodic leg movement disorder) PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Availability of a CD player and head or earphones * Ability to complete questionnaires * No uncontrolled chronic pain (i.e., pain score of ≥ 4 on Numeric Analogue Sleep and Pain Scale) * No diagnosis of major depression disorder, acute anxiety disorder, or schizophrenia per medical record * No hot flashes that interrupt sleep * Not working overnight hours and unable to change schedule * No emotional, psychological, or physical state that, according to physician and/or study personnel evaluation, would preclude adherence to daily home intervention implementation PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 4 days since prior corticosteroid, including inhaled steroids, of any dose for \> 2 days * No prior experience with guided imagery or cognitive behavioral therapy for insomnia * No concurrent new herbal therapies * Stable dose of daily herbal supplements started ≥ 8 weeks before study intervention allowed * Herbal teas or herbs in various drink products allowed * No concurrent treatment with variable doses of any of the following: * Antidepressants * Anxiolytics * Pain medication (not including over the counter ad anti-inflammatory pain relievers) * Pharmacologic treatment for sleep/wake disturbances is allowed, but must be used for 4 weeks before study entry, and can be used daily or intermittently

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (193)

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259-5499, United States

Location

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

Location

Lakeland Regional Cancer Center at Lakeland Regional Medical Center

Lakeland, Florida, 33805, United States

Location

Florida Hospital - Orlando

Orlando, Florida, 32803, United States

Location

Phoebe Putney Memorial Hospital

Albany, Georgia, 31701, United States

Location

Oncare Hawaii Inc-POB II

Honolulu, Hawaii, 96813, United States

Location

Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Straub Clinic and Hospital, Incorporated

Honolulu, Hawaii, 96813, United States

Location

University of Hawaii

Honolulu, Hawaii, 96813, United States

Location

OnCare Hawaii, Incorporated - Kuakini

Honolulu, Hawaii, 96817-3169, United States

Location

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

Location

Castle Medical Center

Kailua, Hawaii, 96734, United States

Location

Wilcox Memorial Hospital and Kauai Medical Clinic

Lihue, Hawaii, 96766, United States

Location

Oncare Hawaii, Incorporated - Pali Momi

‘Aiea, Hawaii, 96701, United States

Location

Pali Momi Medical Center

‘Aiea, Hawaii, 96701, United States

Location

Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

Boise, Idaho, 83706, United States

Location

Saint Alphonsus Regional Medical Center

Boise, Idaho, 83706, United States

Location

Weiss Memorial Hospital

Chicago, Illinois, 60640, United States

Location

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, 46107, United States

Location

Elkhart Clinic, LLC

Elkhart, Indiana, 46514-2098, United States

Location

Michiana Hematology-Oncology, PC - Elkhart

Elkhart, Indiana, 46514, United States

Location

Elkhart General Hospital

Elkhart, Indiana, 46515, United States

Location

Community Howard Regional Health

Kokomo, Indiana, 46904, United States

Location

Howard Community Hospital

Kokomo, Indiana, 46904, United States

Location

Center for Cancer Therapy at LaPorte Hospital and Health Services

La Porte, Indiana, 46350, United States

Location

Michiana Hematology-Oncology, PC - South Bend

Mishawaka, Indiana, 46545-1470, United States

Location

Saint Joseph Regional Medical Center

Mishawaka, Indiana, 46545-1470, United States

Location

Michiana Hematology Oncology PC - Plymouth

Plymouth, Indiana, 46563, United States

Location

Reid Hospital & Health Care Services

Richmond, Indiana, 47374, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

Michiana Hematology Oncology PC-South Bend

South Bend, Indiana, 46601, United States

Location

Michiana Hematology Oncology PC - La Porte

Westville, Indiana, 46391, United States

Location

Cedar Rapids Oncology Associates

Cedar Rapids, Iowa, 52403, United States

Location

Mercy Hospital

Cedar Rapids, Iowa, 52403, United States

Location

Mercy Regional Cancer Center at Mercy Medical Center

Cedar Rapids, Iowa, 52403, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Mercy Cancer Center at Mercy Medical Center - North Iowa

Mason City, Iowa, 50401, United States

Location

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, 51101, United States

Location

Mercy Medical Center - Sioux City

Sioux City, Iowa, 51102, United States

Location

St. Luke's Regional Medical Center

Sioux City, Iowa, 51104, United States

Location

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, 67042, United States

Location

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, 66701, United States

Location

Cancer Center of Kansas-Independence

Independence, Kansas, 67301, United States

Location

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, 67068, United States

Location

Lawrence Memorial Hospital

Lawrence, Kansas, 66044, United States

Location

Cancer Center of Kansas, PA - Liberal

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas-Liberal

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas, PA - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, 67357, United States

Location

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas, PA - Salina

Salina, Kansas, 67401, United States

Location

Cancer Center of Kansas, PA - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health, PA - North Review

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, PA - Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas, PA - Winfield

Winfield, Kansas, 67156, United States

Location

Ochsner Clinic Foundation-Baton Rouge

Baton Rouge, Louisiana, 70809, United States

Location

Ochsner Baptist Medical Center

New Orleans, Louisiana, 70115, United States

Location

Ochsner Cancer Institute at Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Bixby Medical Center

Adrian, Michigan, 49221, United States

Location

Toledo Clinic Cancer Centers - Adrian

Adrian, Michigan, 49221, United States

Location

Saint Joseph Mercy Cancer Center

Ann Arbor, Michigan, 48106-0995, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

Oakwood Cancer Center at Oakwood Hospital and Medical Center

Dearborn, Michigan, 48123-2500, United States

Location

Saint John Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

Van Elslander Cancer Center at St. John Hospital and Medical Center

Grosse Pointe Woods, Michigan, 48236, United States

Location

Allegiance Health

Jackson, Michigan, 49201, United States

Location

Foote Memorial Hospital

Jackson, Michigan, 49201, United States

Location

Sparrow Regional Cancer Center

Lansing, Michigan, 48912-1811, United States

Location

St. Mary Mercy Hospital

Livonia, Michigan, 48154, United States

Location

Mercy Memorial Hospital - Monroe

Monroe, Michigan, 48162, United States

Location

Toledo Clinic Cancer Centers - Monroe

Monroe, Michigan, 48162, United States

Location

St. Joseph Mercy Oakland

Pontiac, Michigan, 48341-2985, United States

Location

Mercy Regional Cancer Center at Mercy Hospital

Port Huron, Michigan, 48060, United States

Location

Seton Cancer Institute at Saint Mary's - Saginaw

Saginaw, Michigan, 48601, United States

Location

Lakeland Regional Cancer Care Center - St. Joseph

Saint Joseph, Michigan, 49085, United States

Location

Lakeside Cancer Specialists, PLLC

Saint Joseph, Michigan, 49085, United States

Location

Marie Yeager Cancer Center

Saint Joseph, Michigan, 49085, United States

Location

St. John Macomb Hospital

Warren, Michigan, 48093, United States

Location

Essentia Health - Duluth Clinic

Duluth, Minnesota, 55805-1983, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Miller - Dwan Medical Center

Duluth, Minnesota, 55805, United States

Location

Immanuel St. Joseph's

Mankato, Minnesota, 56002, United States

Location

Mayo Clinic Health Systems-Mankato

Mankato, Minnesota, 56002, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CentraCare Clinic - River Campus

Saint Cloud, Minnesota, 56303, United States

Location

Coborn Cancer Center

Saint Cloud, Minnesota, 56303, United States

Location

Saint Cloud Hospital

Saint Cloud, Minnesota, 56303, United States

Location

Central Care Cancer Center-Carrie J Babb Cancer Center

Bolivar, Missouri, 65613, United States

Location

Southeast Cancer Center

Cape Girardeau, Missouri, 63703, United States

Location

Capital Region Medical Center-Goldschmidt Cancer Center

Jefferson City, Missouri, 65109, United States

Location

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, 65401, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65802, United States

Location

Mercy-Springfield

Springfield, Missouri, 65804, United States

Location

Ozark Health Ventures LLC dba Cancer Research for the Ozarks - Springfield

Springfield, Missouri, 65804, United States

Location

St. John's Regional Health Center

Springfield, Missouri, 65804, United States

Location

Cox Medical Center

Springfield, Missouri, 65807, United States

Location

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, 65807, United States

Location

Missouri Baptist Cancer Center

St Louis, Missouri, 63131, United States

Location

Montana Cancer Consortium CCOP

Billings, Montana, 59101, United States

Location

Saint Vincent Healthcare

Billings, Montana, 59101, United States

Location

Frontier Cancer Center and Blood Institutes - Billings

Billings, Montana, 59102, United States

Location

Billings Clinic

Billings, Montana, 59107-7000, United States

Location

Bozeman Deaconess Cancer Center

Bozeman, Montana, 59715, United States

Location

Saint James Community Hospital and Cancer Treatment Center

Butte, Montana, 59701, United States

Location

Benefis Healthcare - Sletten Cancer Institute

Great Falls, Montana, 59405, United States

Location

Saint Peter's Community Hospital

Helena, Montana, 59601, United States

Location

Kalispell Regional Medical Center

Kalispell, Montana, 59901, United States

Location

Montana Cancer Specialists

Missoula, Montana, 59802, United States

Location

Saint Patrick Hospital - Community Hospital

Missoula, Montana, 59802, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

Nevada Cancer Research Foundation CCOP

Las Vegas, Nevada, 89106, United States

Location

Saint Joseph Hospital

Nashua, New Hampshire, 03060, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Hematology Oncology Associates of Central New York PC

East Syracuse, New York, 13057, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Margaret R Pardee Memorial Hospital

Hendersonville, North Carolina, 28791, United States

Location

Rutherford Hospital

Rutherfordton, North Carolina, 28139, United States

Location

Toledo Clinic Cancer Centers - Bowling Green

Bowling Green, Ohio, 43402, United States

Location

Adena Regional Medical Center

Chillicothe, Ohio, 45601, United States

Location

Riverside Methodist Hospital Cancer Care

Columbus, Ohio, 43214-3998, United States

Location

CCOP - Columbus

Columbus, Ohio, 43215, United States

Location

Grant Medical Center Cancer Care

Columbus, Ohio, 43215, United States

Location

Mount Carmel Health - West Hospital

Columbus, Ohio, 43222, United States

Location

Doctors Hospital at Ohio Health

Columbus, Ohio, 43228, United States

Location

Grandview Hospital

Dayton, Ohio, 45405, United States

Location

Good Samaritan Hospital

Dayton, Ohio, 45406, United States

Location

David L. Rike Cancer Center at Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Samaritan North Cancer Care Center

Dayton, Ohio, 45415, United States

Location

CCOP - Dayton

Dayton, Ohio, 45420, United States

Location

Grady Memorial Hospital

Delaware, Ohio, 43015, United States

Location

Community Health Partners Regional Medical Center - Mercy Cancer Center

Elyria, Ohio, 44035, United States

Location

Hematology Oncology Center Incorporated

Elyria, Ohio, 44035, United States

Location

Blanchard Valley Medical Associates

Findlay, Ohio, 45840, United States

Location

Middletown Regional Hospital

Franklin, Ohio, 45005-1066, United States

Location

Wayne Hospital

Greenville, Ohio, 45331, United States

Location

Charles F. Kettering Memorial Hospital

Kettering, Ohio, 45429, United States

Location

Fairfield Medical Center

Lancaster, Ohio, 43130, United States

Location

Lima Memorial Hospital

Lima, Ohio, 45804, United States

Location

Strecker Cancer Center at Marietta Memorial Hospital

Marietta, Ohio, 45750, United States

Location

Toledo Radiation Oncology at Northwest Ohio Oncology Center

Maumee, Ohio, 43537, United States

Location

Knox Community Hospital

Mount Vernon, Ohio, 43050, United States

Location

Licking Memorial Cancer Care Program at Licking Memorial Hospital

Newark, Ohio, 43055, United States

Location

Saint Charles Hospital

Oregon, Ohio, 43616, United States

Location

Toledo Clinic Cancer Centers - Oregon

Oregon, Ohio, 43616, United States

Location

Southern Ohio Medical Center Cancer Center

Portsmouth, Ohio, 45662, United States

Location

Community Hospital of Springfield and Clark County

Springfield, Ohio, 45505, United States

Location

Flower Hospital

Sylvania, Ohio, 43560, United States

Location

Mercy Hospital of Tiffin

Tiffin, Ohio, 44883, United States

Location

The Toledo Hospital/Toledo Children's Hospital

Toledo, Ohio, 43606, United States

Location

Saint Vincent Mercy Medical Center

Toledo, Ohio, 43608, United States

Location

University of Toledo

Toledo, Ohio, 43614, United States

Location

Mercy Cancer Center - Saint Anne Mercy Hospital

Toledo, Ohio, 43623, United States

Location

UVMC Cancer Care Center at Upper Valley Medical Center

Troy, Ohio, 45373-1300, United States

Location

Fulton County Health Center

Wauseon, Ohio, 43567, United States

Location

Mount Carmel St. Ann's Cancer Center

Westerville, Ohio, 43081, United States

Location

Ruth G. McMillan Cancer Center at Greene Memorial Hospital

Xenia, Ohio, 45385, United States

Location

Genesis - Good Samaritan Hospital

Zanesville, Ohio, 43701, United States

Location

Natalie Warren Bryant Cancer Center at St. Francis Hospital

Tulsa, Oklahoma, 74136, United States

Location

Geisinger Cancer Institute at Geisinger Health

Danville, Pennsylvania, 17822-0001, United States

Location

Adams Cancer Center

Gettysburg, Pennsylvania, 17325, United States

Location

Geisinger Hazleton Cancer Center

Hazleton, Pennsylvania, 18201, United States

Location

Geisinger Medical Group - Scenery Park

State College, Pennsylvania, 16801, United States

Location

Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

WellSpan Health-York Hospital

York, Pennsylvania, 17405, United States

Location

AnMed Cancer Center

Anderson, South Carolina, 29621, United States

Location

Cancer Centers of the Carolinas - Faris Road

Greenville, South Carolina, 29605, United States

Location

Greenville Cancer Center of the Carolinas (CCOP)

Greenville, South Carolina, 29615, United States

Location

Cancer Centers of the Carolinas-Greer Medical Oncology

Greer, South Carolina, 29650, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Cancer Centers of the Carolinas - Spartanburg

Spartanburg, South Carolina, 29307, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

Fredericksburg Oncology Inc.

Fredericksburg, Virginia, 22401, United States

Location

Marshfield Clinic Cancer Care at Regional Cancer Center

Eau Claire, Wisconsin, 54701, United States

Location

Gundersen Lutheran Health System/CCOP

La Crosse, Wisconsin, 54601, United States

Location

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, 54449, United States

Location

Marshfield Clinic - Lakeland Center

Minocqua, Wisconsin, 54548, United States

Location

Marshfield Clinic-Minocqua Center

Minocqua, Wisconsin, 54548, United States

Location

Marshfield Clinic at James Beck Cancer Center

Rhinelander, Wisconsin, 54501, United States

Location

Ministry Medical Group at Saint Mary's Hospital

Rhinelander, Wisconsin, 54501, United States

Location

Marshfield Clinic - Indianhead Center

Rice Lake, Wisconsin, 54868, United States

Location

Marshfield Clinic-Rice Lake Center

Rice Lake, Wisconsin, 54868, United States

Location

Marshfield Clinic at Saint Michael's Hospital

Stevens Point, Wisconsin, 54481, United States

Location

Marshfield Clinic - Weston Center

Weston, Wisconsin, 54476, United States

Location

Marshfield Clinic - Wisconsin Rapids Center

Wisconsin Rapids, Wisconsin, 54494, United States

Location

Related Publications (1)

• Barton DL, Atherton PJ, Satele DV, Qin R, Dakhil S, Pipe T, Hobday T, Fee-Schroeder K, Loprinzi CL. A randomized phase II trial evaluating two non-pharmacologic interventions in cancer survivors for the treatment of sleep-wake disturbances: NCCTG N07C4 (Alliance). Support Care Cancer. 2020 Dec;28(12):6085-6094. doi: 10.1007/s00520-020-05461-6. Epub 2020 Apr 19.

  PMID: 32307658 DERIVED

MeSH Terms

Conditions

Fatigue; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Neurologic Manifestations; Mental Disorders

Results Point of Contact

• Title: Charles Lawrence Loprinzi, M.D.
• Organization: Mayo Clinic

cloprinzi@mayo.edu

Study Officials

• Debra Barton, RN, PhD, AOCN, FAAN

  Mayo Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2009
• First Posted: October 14, 2009
• Study Start: April 1, 2010
• Primary Completion: March 1, 2014
• Study Completion: May 1, 2019
• Last Updated: December 3, 2019
• Results First Posted: March 3, 2017

Record last verified: 2019-11

Locations

US (193)